NEW YORK, May 20, 2004 (PRIMEZONE) Parker & Waichman LLP (http://www.yourlawyer.com) is calling on Bristol Myers Squibb (NYSE:BMY – News) to immediately stop the sale of Serzone by formally recalling the drug. Yesterday, Bristol Myers Squibb announced that it would stop the shipment of Serzone on June 14, 2004 citing financial reasons. However, Parker & Waichman believes this action does not adequately protect U.S. patients and believes that the continued shipment of Serzone, which has been associated with serious cases of liver damage and death, is grossly irresponsible. Bristol Myers Squibb has already ceased selling Serzone in most other countries.
Parker & Waichman has been an advocate for Serzone side effects victims for over two years and has been retained by over 100 individuals who have developed liver damage as a result of Serzone. Parker & Waichman will file additional claims against Bristol Myers Squibb in the next several weeks. All Serzone and generic Nefazodone users can receive a free case evaluation by visiting: (http://www.serzonelawyernetwork.com).
Parker & Waichman is also encouraging the FDA to immediately remove generic versions of Serzone from the U.S. market. Generic versions of Serzone are sold by Eon Labs Inc, Roxane Laboratories, Mylan Pharmaceuticals Inc, Watson Laboratories and Geneva Pharmaceuticals.
Serzone was removed from the European market on January 8, 2003 after it was linked to 26 deaths from liver damage. Serzone was removed from the Canadian market on November 10, 2003 after Health Canada announced the drug had been linked to at least 38 reported cases of liver-related adverse effects, including one death in Canada.
The FDA issued a “Black-Box” warning for Serzone in December 2001. The “Black-Box” designation refers to a black outline surrounding a section of the label and in the Physicians’ Desk Reference. A “Black-Box” warning is generally reserved for only the most serious side effects. The FDA required Bristol-Myers to warn doctors by letter that patients could suffer severe liver failure that could lead to death or necessitate a liver transplant.
“While we are pleased that Serzone’s days are numbered in the United States we are troubled that Bristol Myers Squibb did not recall the drug immediately,” commented Jerrold S. Parker, one of the founding partners of Parker & Waichman. “Bristol Myers Squibb allowed this drug to stay on the American market for over one year after it was taken off the European markets. We will continue to ask Bristol Myers Squibb why the lives of European and Canadian Serzone users were better protected than their American counterparts. We are committed to seeking justice on behalf of all Serzone users and their families who have suffered life threatening injuries from this dangerous drug.”
Serzone (generic name nefazodone hydrochloride) was approved by the FDA for use in the United States for the treatment of depression in 1994. In 2003, Serzone sales were in excess of $100 million. Serzone has not been shown to be more effective in treating depression than other drugs in its class.
More information on Serzone side effects is available at Parker & Waichman’s Serzone website: (http://www.serzonelawyernetwork.com) and at: (http://yourlawyer.com/practice/overview.htm?topic=Serzone). All Serzone users can visit this site to request a free legal evaluation.
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